Information Systems-enabled Outreach Program for Adverse Drug Events

Adverse Drug Events Clinical Trial

— ISTOP-ADE  

Official title:

Information Systems-enabled Outreach Program for Adverse Drug Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059044
• Other study ID #: 20130285
• Secondary ID: MOP125975
• Status: Completed
• Phase: N/A
• Start date: October 15, 2015
• Est. completion date: March 31, 2019

Study information

• Verified date: May 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of the most common health care interventions in any healthcare setting is a medication prescription. Unfortunately, up to 25% of outpatient prescriptions are associated with adverse drug events (ADEs). ADEs decrease patient health directly and can lead to non-adherence, which in turn has negative consequences.

The investigators recently conducted a pilot project in which the feasibility and potential utility of an information technology enabled outreach program for monitoring patients receiving an outpatient prescription was tested. This intervention involved the use of an interactive voice response system programmed to automatically call ambulatory care patients following a prescription. If the system identified a potential medication problem, a pharmacist was notified who contacted the patient, modified the therapy accordingly, and informed a physician when necessary.

The pilot project included 568 patients with diverse illnesses in two Canadian cities. High levels of patient and provider acceptability of the system were determined from 21 day interviews. The program identified 56 of 125 (45%) ADEs and 10 of 26 (30%) of primary non-compliance events. Very few episodes of ameliorable ADEs were observed.

The investigators feel these results justify a randomized control trial to assess the effectiveness of the intervention for improving patient centered outcomes. Ambulatory care patients receiving incident prescriptions for one of four conditions (hypertension, diabetes mellitus, depression, and anxiety) will be randomized to the intervention or routine care. The investigators expect that the system will reduce the severity and duration of outpatient ADEs and improve adherence to medication care.

Description:

One of the most common health care interventions in any healthcare setting is a medication prescription. On an individual and population level, outpatient medication use has the potential to improve health. Unfortunately, up to 25% of outpatient prescriptions are associated with adverse drug events (ADEs). ADEs decrease patient health directly and can lead to non-adherence, which in turn has negative consequences.

The investigators recently conducted a pilot project in which the feasibility and potential utility of an information technology enabled outreach program for monitoring patients receiving an outpatient prescription was tested. This intervention involved the use of an interactive voice response system programmed to automatically call ambulatory care patients following a prescription. If the system identified a potential medication problem, a pharmacist was notified who subsequently contacted the patient, modified the therapy accordingly, and informed a physician when necessary.

The pilot project included 568 patients with diverse illnesses in two Canadian cities (Montreal and Quebec City). The system successfully contacted 477 patients (84%). High levels of patient and provider acceptability of the system were determined from 21 day interviews. The program identified 56 of 125 (45%) ADEs and 10 of 26 (30%) of primary non compliance events. Very few episodes of ameliorable ADEs were observed in which the ADE severity could have been diminished with more appropriate management.

The investigators feel these results justify a randomized control trial to assess the effectiveness of our intervention for improving patient-centered outcomes. To determine whether the system reduces the severity and duration of outpatient ADEs and improves adherence to medication care at three and 12 months, ambulatory care patients receiving incident prescriptions for one of four conditions (hypertension, diabetes mellitus, depression, and anxiety) will be randomized to the intervention or routine care. As an exploratory analysis, the impact of the intervention on patient self efficacy and health services use will also be examined.

This study will help to define whether this promising intervention can improve patient health from both the individual patient and population health perspective. There is a wide scope of potential applications for this approach. This study will provide important information to guide these future applications beyond the specific question asked in this protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: March 31, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• spoken language is French or English

• physician is a user of MOXXI (electronic health record system) and patient has consented to be captured by MOXXI

• receiving a high-risk incident prescription

• medication insurance through Regie de l'Assurances Maladie du Quebec (RAMQ) insurance program

Exclusion Criteria:

• patient not appropriate for inclusion (as determined by prescribing physician)

Related Conditions & MeSH terms

• Adverse Drug Events
• Drug-Related Side Effects and Adverse Reactions

Intervention

Other:
• ISTOP-ADE
Interactive Voice Response System + Pharmacist

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR), McGill University

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Auger C, Forster AJ, Oake N, Tamblyn R. Usability of a computerised drug monitoring programme to detect adverse drug events and non-compliance in outpatient ambulatory care. BMJ Qual Saf. 2013 Apr;22(4):306-16. doi: 10.1136/bmjqs-2012-001492. Epub 2013 Feb 8. — View Citation

Forster AJ, Auger C; ISTOP ADE Investigators. Using information technology to improve the monitoring of outpatient prescribing. JAMA Intern Med. 2013 Mar 11;173(5):382-4. doi: 10.1001/jamainternmed.2013.2002. — View Citation

Forster AJ, Boyle L, Shojania KG, Feasby TE, van Walraven C. Identifying patients with post-discharge care problems using an interactive voice response system. J Gen Intern Med. 2009 Apr;24(4):520-5. doi: 10.1007/s11606-009-0910-3. Epub 2009 Jan 21. — View Citation

Forster AJ, LaBranche R, McKim R, Faught JW, Feasby TE, Janes-Kelley S, Shojania KG, van Walraven C. Automated patient assessments after outpatient surgery using an interactive voice response system. Am J Manag Care. 2008 Jul;14(7):429-36. — View Citation

Forster AJ, van Walraven C. Using an interactive voice response system to improve patient safety following hospital discharge. J Eval Clin Pract. 2007 Jun;13(3):346-51. — View Citation

Oake N, Jennings A, van Walraven C, Forster AJ. Interactive voice response systems for improving delivery of ambulatory care. Am J Manag Care. 2009 Jun;15(6):383-91. Review. — View Citation

Oake N, van Walraven C, Rodger MA, Forster AJ. Effect of an interactive voice response system on oral anticoagulant management. CMAJ. 2009 Apr 28;180(9):927-33. doi: 10.1503/cmaj.081659. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of intervention for each patient		21 days following prescription (average)
Primary	Failure to persist with medication regimen		6 months
Secondary	Proportion of patients experiencing an ADE		within 30 days of prescription
Secondary	Duration of symptoms attributable to the ADE from start to resolution		within 21 days following prescription
Secondary	ADE resulting in an Emergency Department (ED) or inpatient encounter		within 21 days following prescription
Secondary	ADE severity		within 30 days of prescription
Secondary	Proportion of patients experiencing an ameliorable ADE	An ameliorable ADE is an ADE whose severity should have been reduced if the healthcare system responded to the patient's health issues in an appropriate manner	within 30 days of prescription
Secondary	Healthcare utilization (number of visits to MDs, EDs, days in hospital, and medication claims)		1 year